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Monday Poster Session
Category: Esophagus
Santosh Kale, MD
Nassau University Medical Center
East Meadow, NY, United States
Study/ Year | Design | Drug/ Dose and Duration of therapy | Number of Children | Number of Adults | Number of Males (%) | Histologic Diagnostic Criteria | Primary Histologic Endpoint | Clinical Endpoint | Study Duration | PPI trial done before & during the study |
Budesonide suspension vs placebo |
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Dellon 2017 | Modified ITT
| Budesonide Oral Suspension 2 mg BID/12 weeks | 35 Not equal to analysed | 58 | 64 (68.81%) | > 15 eos/hpf | <6 eos/hpf | Dysphagia Symptom Questionnaire (Validated) | 12 weeks | Yes |
Dohil 2010 | Modified ITT
| Oral Viscous Budesonide / 1-2 mg daily/ 3 months | 23 –equal to analysed | 0 | 20 (86.95 %) | > 20 eos/hpf | <6 eos/hpf (response) | Symptom Scoring Tool (Non – validated) | 3 months | Yes |
Gupta 2015 | Modified ITT
| Budesonide, Low (0.35 mg ), Medium (1.4 mg) & High Dose Suspension (2.8 mg)/12 weeks | 71 equal to analyzed | None | 57 (80.28%) | > 20 eos/hpf | < 6 eos/hpf | EoE Clinical Symptom Score (Non-validated) | 12 weeks | Yes |
Lucendo 2019 | ITT
| Budesonide Oral Tablet 1 mg BID | None Equal to analysed | 88 | 73 (82.95%) | > 20 eos/hpf | < 5 eos/hpf | NRS for Dysphagia & Odynophagia Score | 6 weeks | Yes |
Straumann 2010 | ITT
| Budesonide/ 1 mg BID Suspension /15 days | 2 = analysed | 34 | 31 (86.11%) | > 20 eos/hpf | < 4 eos/hpf | Dysphagia Score (non-validated) | 15 days | N.A. |
Miehlke 2016 | Modified ITT (study stopped early)
| Budesonide 2 mg Tablet, 4 mg tablet and Budesonide Viscous Solution | None = analysed | 76 | 63 (82.89%) | > 16 eos/mm2, and peak eosinophil > 65 /mm2 hpf | < 16 eos/mm2 hpf
(remission) | Dysphagia Score (Non – Validated) | 2 weeks | Yes |
Fluticasone vs placebo | ||||||||||
Alexander 2012 | ITT
| Aerosolized Fluticasone /880 ug BID / 6 weeks | None = analysed | 42 | 34 (80.95%) |
| More than 90% decrease in mean Eos count | Validated Mayo Dysphagia Questionnaire | 6 weeks | Yes |
Butz 2014 | Modified ITT (study stopped early)
| Aerosolized Fluticasone / 1760 ug daily/ 3 months | 29 Not equal to analysed | 7 | 35 | > 24 eos/hpf | < 1 eos/hpf | Symptoms of EoE | 3 months | Yes |
Konikoff 2006 | Per protocol
| Aerosolized Fluticasone /880 ug BID/3months | 31 = analysed | None | 26 (72.22%) | > 24 eos/hpf | < 1 eos/hpf (remission) | NA | 3 months | Yes but usage before the study not mentioned |